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Clinical Trials/NCT05453955
NCT05453955
Completed
Not Applicable

Influence of Propofol and Remimazolam on Intraoperative Responses of Motor Evoked Potentials During Spine Surgery

Korea University Guro Hospital1 site in 1 country20 target enrollmentAugust 1, 2022

Overview

Phase
Not Applicable
Intervention
Propofol
Conditions
Spine Disease
Sponsor
Korea University Guro Hospital
Enrollment
20
Locations
1
Primary Endpoint
Motor evoked potential (MEP), before cross-over
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

This study was planned to investigate the degree of effect of remimazolam on MEP compared to propofol when monitoring the motion-inducing potential (MEP).

Registry
clinicaltrials.gov
Start Date
August 1, 2022
End Date
February 7, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Seok Kyeong Oh

Assistant Professor

Korea University Guro Hospital

Eligibility Criteria

Inclusion Criteria

  • Aged 20-70
  • Scheduled for elective spine surgery requiring monitoring of evoked potential
  • ASA physical status 1-3

Exclusion Criteria

  • Uncontrolled DM (HbA1c ≥ 9%)
  • Contraindications to the study drug: known allergy or hypersensitivity
  • Use of rate responsive cardiac pacemaker with bioelectrical impedence
  • Diagnosed neuromuscular disorder
  • Pre-existing motor weakness

Arms & Interventions

Propofol-Remimazolam

General anesthesia was induced and maintained with propofol, then switched to remimazolam after 60 minutes from incision.

Intervention: Propofol

Propofol-Remimazolam

General anesthesia was induced and maintained with propofol, then switched to remimazolam after 60 minutes from incision.

Intervention: Remimazolam Besylate

Remimazolam-Propofol

General anesthesia was induced and maintained with remimazolam, then changed to propofol after 60 minutes from incision.

Intervention: Propofol

Remimazolam-Propofol

General anesthesia was induced and maintained with remimazolam, then changed to propofol after 60 minutes from incision.

Intervention: Remimazolam Besylate

Outcomes

Primary Outcomes

Motor evoked potential (MEP), before cross-over

Time Frame: Intraoperative, just after confirmation of neuromuscular recovery, for 30 minutes

Amplitude and latency of MEP before cross-over

MEP, after cross-over

Time Frame: Intraoperative, 30 minutes after alteration of the maintenance drug, for 30 minutes

Amplitude and latency of MEP after cross-over

Secondary Outcomes

  • Bispectral index(Intraoperative)
  • Heart rate(Intraoperative)
  • Blood pressure(Intraoperative)

Study Sites (1)

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